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US official says European patients 'guinea pigs'
Source: Agencies |
February 26, 2011, Saturday
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A TRANSATLANTIC spat has erupted after a top US official suggested European patients may be "guinea pigs" for medical devices with less government oversight.
A senior official at the European Commission complained to the United States Food and Drug Administration this month about comments from the FDA's device chief, Dr Jeffrey Shuren.
In defending US device standards, Shuren has highlighted a few products that were approved in Europe but not in the US and were later pulled from the market for safety reasons.
Speaking to reporters on a conference call in January, he quoted a plastic surgeon as saying: "Under the EU system, the public are being used as guinea pigs."
Paola Testori Coggi, head of the European Commission's health and consumers department, objected to Shuren's remarks in a letter to FDA Commissioner Margaret Hamburg.
"I am deeply concerned that a senior official of the FDA should publicly discredit the regulatory system in Europe in this way," Coggi wrote in a February 18 letter.
The FDA has been criticized by device makers who say regulatory requirements are too inconsistent and unpredictable and discourage development of new technologies.
Both the US and European regulatory systems, "though on different paths, seek to secure a high level of patient safety," Coggi said. If the FDA has evidence of unsafe devices on sale in Europe, "I would appreciate if you could share this information with European -regulators," she added.
EC spokesman Frederic Vincent said the letter was sent to "clarify the issue and pass on a clear message."
FDA spokeswoman Karen Riley said the FDA and European regulators "continue to have a very collaborative relationship" that has "benefited both of us quite well for many years."
In testimony to the US Congress last week, Shuren said Europe's -system did not require a government review before a company could -market a device.
A senior official at the European Commission complained to the United States Food and Drug Administration this month about comments from the FDA's device chief, Dr Jeffrey Shuren.
In defending US device standards, Shuren has highlighted a few products that were approved in Europe but not in the US and were later pulled from the market for safety reasons.
Speaking to reporters on a conference call in January, he quoted a plastic surgeon as saying: "Under the EU system, the public are being used as guinea pigs."
Paola Testori Coggi, head of the European Commission's health and consumers department, objected to Shuren's remarks in a letter to FDA Commissioner Margaret Hamburg.
"I am deeply concerned that a senior official of the FDA should publicly discredit the regulatory system in Europe in this way," Coggi wrote in a February 18 letter.
The FDA has been criticized by device makers who say regulatory requirements are too inconsistent and unpredictable and discourage development of new technologies.
Both the US and European regulatory systems, "though on different paths, seek to secure a high level of patient safety," Coggi said. If the FDA has evidence of unsafe devices on sale in Europe, "I would appreciate if you could share this information with European -regulators," she added.
EC spokesman Frederic Vincent said the letter was sent to "clarify the issue and pass on a clear message."
FDA spokeswoman Karen Riley said the FDA and European regulators "continue to have a very collaborative relationship" that has "benefited both of us quite well for many years."
In testimony to the US Congress last week, Shuren said Europe's -system did not require a government review before a company could -market a device.
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